Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “UChek’s Response to an FDA Letter: An Unfolding Saga.”
Following is an excerpt:
At TED this year, Myshkin Ingawale of Biosense Technologies, Mumbai, India, announced the launch of an app that lets you test your urine. At the time, the product, called uChek, drew laughs from the audience as inevitable jokes of peeing on your phone riffled through the audience.
But the app is of course smarter, and more valuable than that.
At the time, Brad Thompson wrote an editorial for MD+DI, asking whether the app was really a medical device. At that point, Biosense seemed to be trying to avoid medical device status, based on the company’s press materials, which stated that uChek is not intended to treat, cure, mitigate, or prevent disease.
“Everyone in the medical device industry probably recognizes that the company is trying to distinguish its intended use from one meeting the FDA’s medical device definition,” noted Thompson in his editorial.